Job Description

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.

They are seeking a Sr. R&D Engineer – Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.

DUTIES / EXPECTATIONS OF THIS ROLE

· Prepare and present structured technical documentation and summaries for internal and external stakeholders.

· Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports.

· Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software).

· Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities.

· Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment.

· Participate in and/or lead formal design reviews, risk reviews, and test planning sessions.

· Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations.

· Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971.

MUST HAVES - QUALIFICATION SUMMARY

· Bachelor’s or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience).

· 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred).

· Proven experience authoring and managing requirements, traceability matrix, and risk documentation.

· Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.

· Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies.

· Strong attention to detail with a systematic approach to documentation and traceability.

· Excellent organizational and communication skills with the ability to manage multiple priorities.

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